BMGF – Gates Foundation [to 17 February 2018]
Gates Notes | 13 February 2018
Gates Annual Letter: The 10 Toughest Questions We Get
…We’ve spent $15.3 billion on vaccines over the past 18 years. And it’s been a terrific investment. Better immunization is one reason why the number of children who die has gone down by so much, from almost 10 million in 2000 to 5 million last year…
European Vaccine Initiative [to 17 February 2018]
14 February 2018
Sustained support by SAP business ByDesign to EVI’s mission
European Vaccine Initiative (EVI) begins its third decade developing vaccines for diseases against poverty.
FDA [to 17 February 2018]
February 15, 2018 –
Statement from FDA Commissioner Scott Gottlieb, M.D. on the efficacy of the 2017-2018 influenza vaccine
[See Milestones/Perspectives above for full text]
February 15, 2018 –
Statement from FDA Commissioner Scott Gottlieb, M.D. on advancing the development of novel treatments for neurological conditions; part of broader effort on modernizing FDA’s new drug review programs
February 14, 2018 –
FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint
February 13, 2018 –
Statement from FDA Commissioner Scott Gottlieb, M.D., on Administration’s request for new FDA funding to promote innovation and broaden patient access through competition
Create a New Medical Data Enterprise: Advance the Use of Real-World Evidence to Improve Human and Animal Health and Support Pre-Market Evaluation and Post-Market Safety
The FDA will advance the use of real-world experience to better inform patient care and provide more efficient, robust and potentially lower-cost ways to develop clinical data that can inform product review and promote innovation. The FDA will establish a new capability, including the development of data and analytical tools, to conduct near-real-time evidence evaluation down to the level of individual electronic health records for at least 10 million individuals in a broad range of U.S. healthcare settings.
Toward these ends, an expanded use of natural language processing for the assessment of information submitted to the agency would be developed in an effort to markedly speed recognition and remediation of emerging safety concerns. The effort would cover a broad range of medical products, including drugs, biologics and medical devices. The healthcare settings would be carefully selected to cover data gaps in the Sentinel and National Evaluation System for health Technology (NEST) systems for FDA-regulated products not currently easily assessed with existing systems.
Expanding the FDA’s capacity to utilize real-world evidence to evaluate the pre- and post-market safety and effectiveness of medical products would generate processes that could improve the efficiency of the regulatory process, better inform patients and providers about pre-and post-market safety, reduce some of the burdens that drive up the time and cost required to bring beneficial innovations to the market and address barriers that can make certain important safety and effectiveness information around the real-world use of products hard to collect and evaluate. The agency has already leveraged the use of real-world data to reduce the time and cost of clinical evidence development resulting in more timely and informative post-market data collection and more timely and efficient approvals of new devices and expanded indications of already marketed drugs and devices, including for drug-eluting stents, pacing leads, companion diagnostics, a spinal cord stimulator and a pediatric ventricular assist device. In the case of transcatheter heart valves, leveraging real-world evidence has already resulted in a greater than 400 percent cost savings for industry, improved post-market surveillance and moved the United States from 42nd to, in some cases, first-in-the-world approvals for life-saving technologies…
Global Fund [to 17 February 2018]
Indonesia and Global Fund Unveil New Grants
13 February 2018
The Global Fund and health partners in Indonesia yesterday launched six new grants aimed at expanding Indonesia’s ambitious goals against HIV, TB and malaria.
MSF/Médecins Sans Frontières [to 17 February 2018]
Promising MSF Research Highlights Immense Benefits, Need for Expanded Use of DR-TB Drug Combination
February 14, 2018
New research published today in The Lancet Infectious Diseases journal by the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) provides strong evidence that a combination of two new drugs for tuberculosis (TB)—the world’s leading infectious disease killer—could be used to treat drug-resistant (DR-TB) forms of the disease.
Iraq: Urgent Needs Must not be Forgotten as International Conference on Reconstruction Begins
February 12, 2018
An international conference on the reconstruction of Iraq is underway in Kuwait this week. Carla Brooijmans, Doctors Without Borders/Médecins Sans Frontières (MSF) head of mission for Iraq, gave the following statement after a meeting in Kuwait today of aid organizations responding to humanitarian needs in Iraq.
NIH [to 17 February 2018]
February 16, 2018
PHAT Life: Effective HIV intervention for youth in the criminal justice system
Program showed great potential for reducing sexual risk-taking.
PATH [to 17 February 2018]
Announcement | February 12, 2018
PATH statement on the US Administration’s proposed Fiscal Year 2019 budget
The following is a statement from Carolyn Reynolds, PATH’s Vice President for Policy and Advocacy, on the release of the Administration’s Fiscal Year 2019 Budget Request:
“For the second year in a row, the Administration’s budget includes extensive cuts to global health and development programs at the US Agency for International Development (USAID) and the State Department. We are deeply concerned that these cuts not only put lives at risk but also reduce America’s own security and standing in the world. Given the extensive threats we face that require international cooperation and investment, gutting US support for global health and development is the wrong choice for America and for the world…”
UNAIDS [to 17 February 2018]
Promoting women’s leadership in science and health
11 February 2018
The International Day of Women and Girls in Science is celebrated on 11 February. As part of UNAIDS’ Right to Health campaign last year, UNAIDS Special Ambassador for Adolescents and HIV and champion for young women in science, Quarraisha Abdool Karim, spoke with her daughter about her life’s work and the importance of women’s involvement in science and health.
UNICEF [to 17 February 2018]
15 February 2018
Massive data gaps leave refugee, migrant and displaced children in danger and without access to basic services
NEW YORK,– Gaps in data covering refugees, asylum seekers, migrants and internally displaced populations are endangering the lives and wellbeing of millions of children on the move, warned five UN and partner agencies today. In ‘A call to action: Protecting children on the move starts with better data’, UNICEF, UNHCR, IOM, Eurostat and OECD together show how crucial data are to understanding the patterns of global migration and developing policies to support vulnerable groups like children.
Vaccine Confidence Project [to 17 February 2018]
A global girl gang
Heidi J Larson. 2018. The Lancet 391(10120), p527–528. https://doi.org/10.1016/S0140-6736(18)30193-4
[See Reports, Research, Commentary below for full text]
Wellcome Trust [to 17 February 2018]
News / Published: 15 February 2018
Huge global survey to gauge public attitudes to science
Wellcome is funding an ambitious new global study designed to understand how people around the world think and feel about science and key health challenges.
Beginning this spring, and throughout 2018, we will survey 140,000 people from 140 countries. The findings will be available in 2019.
The survey will ask about people’s attitudes towards science to gauge their interest in it and how much they trust it. There are also questions about specific areas of science, eg vaccines, that have universal importance and are a priority for Wellcome.
The 30 questions, which take about ten minutes to complete face to face or over the phone, are part of the 2018 Gallup World Poll.
The Wistar Institute [to 17 February 2018]
Wistar Researchers Garnered More Than $6.5M in Funding to Support New Discoveries in Cancer & Infectious Disease
PHILADELPHIA–(Feb. 13, 2018)–Scientists at The Wistar Institute, an international biomedical research leader in cancer, immunology and infectious diseases, received research funds totaling $6.58 million between the end of 2017 and the first months of 2018.
BIO [to 17 February 2018]
Feb 12 2018
BIO Expresses Strong Support for TRID Improvement Act
Legislation provides critical regulatory relief to small, pre-revenue emerging companies
Washington, D.C. (February 12, 2018)— The Biotechnology Innovation Organization (BIO) announced its strong support today for H.R. 3978, the TRID Improvement Act. The bill includes a provision known as the Fostering Innovation Act, which offers much needed regulatory relief to small biotechnology firms..The Fostering Innovation Act extends one vital JOBS Act provision – the temporary exemption from Section 404(b) of Sarbanes-Oxley (SOX) – for an additional five years for pre-revenue small businesses.